GEN Receives Ethical Approval to Launch Phase II Clinical Trial for SUL-238 Targeting Mitochondrial Dysfunction in Patients with Parkinson’s Disease

GEN announces approval in the Netherlands to initiate patient enrollment in April 2026 for the Phase II Proof of Concept trial of its novel drug candidate SUL-238, Targeting Mitochondrial Dysfunction in Patients with Parkinson's Disease.

ANKARA, TR / ACCESS Newswire / March 16, 2026 / GEN Pharmaceuticals (GENIL.IS), Türkiye's leading specialty pharmaceutical company, announced today that it has received approval in the Netherlands from the BEBO Foundation for the Assessment of Ethics of Biomedical Research (Stichting Beoordeling Ethiek Biomedisch Onderzoek) to proceed with Phase II Proof of Concept Trial for SUL-238 Targeting Mitochondrial Dysfunction in Patients with Parkinson's Disease. With this approval, GEN can now proceed to activate the clinical site in Groningen, the Netherlands. Patient enrollment is planned to start in April 2026.

Details of the Phase II trial, entitled "A Phase 2, Randomized, Double-blind, Placebo-Controlled, Single-Center Study to Assess the effects of SUL-238 on High Energy Phosphates with Magnetic Resonance Spectroscopy (³¹P-MRS) in patients with Early, untreated Parkinson's Disease ("SHEPHERD" STUDY)" can be viewed at clinicaltrials.gov.

Abidin Gülmüş, Chairman of GEN, stated:
"Following the ethical approval, we look forward to starting patient enrollment in the Netherlands.This Phase 2 trial will be another key milestone toward addressing neurodegenerative diseases at its biological foundation."

About Parkinson's Disease
Parkinson's Disease (PD) is the most common neurodegenerative movement disorder affecting up to 2% of those aged above 60 years. The disease follows a progressive course, and there are still no proven strategies for slowing the progression of PD. Mitochondrial dysfunction and oxidative damage are implicated in the pathophysiology of neurodegenerative disorders, including PD and Alzheimer's disease. Since mitochondria are highly multifunctional organelles, their integrity is essential for neuronal function and survival.

About SUL-238
SUL-238 is a novel, first-in-class, hibernation-inspired small molecule designed to target mitochondria, the 'powerhouse' of the cell. SUL-238 supports mitochondrial bioenergetics via complex I/IV activation and enhances mitochondrial function in various preclinical models for neurodegenerative, cardiovascular, and renal diseases, and also in accelerated aging. SUL-238 exhibits a favourable pharmacokinetic profile and a high cerebrospinal fluid penetration, and has undergone extensive safety evaluation in preclinical and clinical Phase 1 studies. GEN licenses SUL-238 from Sulfateq B.V. for neurodegenerative disease applications.

About GEN:
Founded in 1998, GEN is Türkiye's leading specialty pharmaceutical company, focused on developing innovative therapies across multiple therapeutic areas. Through significant R&D investments and global collaborations, GEN is committed to advancing healthcare worldwide. The company develops and manufactures high-quality, competitive products at its GMP-certified production facility and continues its bold efforts in original drug development via two dedicated R&D centers.

About Sulfateq:
Sulfateq B.V. is a Dutch biotech company in Groningen (the Netherlands) that fosters strategic collaborations with academic and industrial research centres to accelerate the development of innovative new medicines. It has developed a novel class of small-molecule SUL compounds that maintain mitochondrial health.

For more information:
www.genilac.com.tr
www.sulfateqbv.com

Press Contacts:
Bulutay GÜNEŞ, Sr. Head of Corporate Brand
b.gunes@genilac.com
Fatih GÖREN, Investor Relations Manager
f.goren@genilac.com
Kees van der Graaf, Chief Executive Officer
info@sulfateqbv.com

SOURCE: GEN Ilac ve Saglik Urunleri A.S.